HYCOR PYLORAGEN HELICOBACTER PYLORI TEST— 510(k) K912255

Name: FDA 510(k) clearance K912255
Creator: U.S. Food and Drug Administration
Published: 1991-10-11

Substantially Equivalent

Hycor Biomedical, Inc.

FDA 510(k) clearance K912255 for HYCOR PYLORAGEN HELICOBACTER PYLORI TEST, Substantially Equivalent on 1991-10-11. Applicant: Hycor Biomedical, Inc.. Device class: 1.

Clearance details

Applicant: Hycor Biomedical, Inc.
Product code: Code LYR
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1991-05-22
Decision date: 1991-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.